CurrentCareSource GeorgiaPolicy GA-MED-P-4499700

Clinical Trial Coverage

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This policy governs CareSource Georgia Medicaid coverage of medically necessary routine care costs for members enrolled in qualifying Phase I-IV clinical trials for cancer or life-threatening diseases. It defines qualifying trials, covered routine care, exclusions, prior authorization, and applicable utilization management and network requirements.

Policy Summary

PayerCareSource Georgia

PolicyClinical Trial Coverage

Policy CodePolicy GA-MED-P-4499700

Change TypeMaterial revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for ICD-10-CM code Z00.6 and apply all other applicable utilization management requirements.

SourceLink

POLICY UPDATE CHANGES

Specific clinical trial coverage criteria were added during the policy revision history.

A prior authorization requirement was added for clinical trial encounter diagnosis code Z00.6.

The policy history indicates that the Z00.6 description was expanded to identify encounters for examination for normal comparison and control in a clinical research program.

Experimental or Investigational Item or Service was added to the related policies/rules section.

4 phasesClinical trial phases addressed

Z00.6Required encounter diagnosis code

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CurrentCareSource GeorgiaPolicy GA-MED-P-4499700

Clinical Trial Coverage

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Sign up for caresourcegeorgia Policy GA-MED-P-4499700 alerts

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Policy Summary

PayerCareSource Georgia

PolicyClinical Trial Coverage

Policy CodePolicy GA-MED-P-4499700

Change TypeMaterial revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for ICD-10-CM code Z00.6 and apply all other applicable utilization management requirements.

SourceLink

POLICY UPDATE CHANGES

Specific clinical trial coverage criteria were added during the policy revision history.

A prior authorization requirement was added for clinical trial encounter diagnosis code Z00.6.

The policy history indicates that the Z00.6 description was expanded to identify encounters for examination for normal comparison and control in a clinical research program.

Experimental or Investigational Item or Service was added to the related policies/rules section.

4 phasesClinical trial phases addressed

Z00.6Required encounter diagnosis code

Routine care coverage requirements

8 exclusionsExcluded cost categories

7 pathwaysFunding or approval pathways

Qualifying Clinical Trial Coverage

Qualifying Clinical Trial

A clinical trial qualifies for coverage when ALL of the following requirements are met:

ALL of the following

ONE of the following trial phases
- Phase I research study
- Phase II research study
- Phase III research study
- Phase IV research study
The study is for the treatment of cancer or a life-threatening disease or condition.
The study does ONE of the following
- Tests how to administer a health care service.
- Tests responses to a health care service.
- Compares the effectiveness of a health care service.
- Studies new uses of a health care service.
The study is approved and funded by ONE of the following
- A cooperative group of research facilities with an established peer review program approved by a National Institutes of Health institute or center, with unbiased review of standards of care by qualified individuals who do not have an interest in the review outcome.
- The National Institutes of Health (NIH).
- The Centers for Disease Control and Prevention (CDC).
- The Agency for Healthcare Research and Quality (AHRQ).
- The Centers for Medicare and Medicaid Services (CMS).
- A cooperative group or center of NIH, CDC, AHRQ, the United States Department of Defense (DOD), the United States Department of Veterans Affairs (VA), or CMS.
The study is conducted in a facility where personnel have the training and expertise required to provide the type of care required in the study.
The study has a written clinical trial protocol.
The study is designed to have therapeutic intent.

Routine Care Cost Coverage

Routine care costs are covered only when ALL of the following conditions are met:

ALL of the following

The member is enrolled in a clinical trial described in this policy.
The same routine care costs would typically be covered for a member who is not enrolled in the clinical trial.
All items and services are medically necessary.
All items and services are a covered benefit.

Trial-Related Administration, Monitoring, or Complications

CareSource covers routine care costs for items or services used for a qualifying clinical trial-related purpose when ALL of the following requirements are met:

ALL of the following

The member is enrolled in a clinical trial described in this policy.
The item or service would typically be covered for a member who is not enrolled in the clinical trial.
The item or service is medically necessary.
The item or service is a covered benefit.
The item or service is used for ONE of the following clinical trial-related purposes

The item or service being evaluated in the clinical trial is excluded from routine care cost coverage.

Items or services used only for data collection and analysis, and not for the direct clinical management of the member, are excluded from routine care cost coverage.

Items or services reimbursed or provided free by another source, including the research sponsor, are excluded from routine care cost coverage.

Items or services used only to determine whether an individual is eligible to participate in the clinical trial are excluded from routine care cost coverage.

Clinical trials designed only to test toxicity or disease pathology are excluded from routine care cost coverage.

Treatment that is not standard of care and is used to support or administer the item or service in the clinical trial is excluded from routine care cost coverage.

Transportation, housing, food, and travel-related expenses for the member, family members, or companions associated with travel to or from the facility providing the clinical trial are excluded from routine care cost coverage.

Experimental, investigational, or unproven procedures, treatments, services, supplies, devices, or products are excluded from routine care cost coverage.

Items and services that are not medically necessary do not qualify for routine care cost coverage.

Clinical Trial Diagnosis Coding

Clinical trial encounter diagnosis codeICD-10Covered

Z00.6

Encounter for examination for normal comparison and control in clinical research program

Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior Authorization and Utilization Management

Obtain prior authorization for ICD-10-CM code Z00.6. All other applicable utilization management requirements, including additional prior authorizations, continue to apply to routine care provided during a clinical trial.

Prior authorization is required for Z00.6.
Apply all applicable utilization management guidelines to routine care for members enrolled in a clinical trial.

Documentation Required

IRB-Approved Informed Consent

Before enrolling a member in a clinical trial, obtain informed consent approved by an Institutional Review Board (IRB) accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and maintain the consent documentation.

IRB-approved informed consent must be obtained before enrollment.

Clinical Trial Coverage Context

Clinical trials are research studies that evaluate new or emerging devices, treatments, procedures, or uses of health care services, sometimes by comparing them with currently accepted treatment. Trials generally progress through four phases: Phase I evaluates safety and dosage, Phase II evaluates effectiveness and side effects, Phase III confirms effectiveness and compares treatment options, and Phase IV evaluates effects and long-term safety after marketing. This policy addresses routine care costs associated with qualifying trials, not the investigational item or service being evaluated.

Key Policy Definitions

Clinical Trial

Study phase and conditionA Phase I, II, III, or IV research study for the treatment of cancer or a life-threatening disease.

Research purposeThe study tests how to administer a health care service, tests responses to a health care service, compares the effectiveness of a health care service, or studies a new use of a health care service.

Approval or fundingThe study is approved and funded by a qualifying governmental, cooperative, institutional, or research entity identified in the policy.

Facility and personnelThe study is conducted in a facility where personnel have the training and expertise required to provide the type of care required in the study.

Protocol and intentThe study has a written protocol and is designed to have therapeutic intent.

Policy Summary

PayerCareSource Georgia

PolicyClinical Trial Coverage

Policy CodePolicy GA-MED-P-4499700

Change TypeMaterial revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for ICD-10-CM code Z00.6 and apply all other applicable utilization management requirements.

SourceLink

On This Page

The United States Department of Veterans Affairs (VA).

The United States Department of Defense (DOD).

The Food and Drug Administration (FDA).

The United States Department of Energy.

The institutional review board of an institution located in Ohio that has a multiple project assurance contract approved by the NIH Office for Protection from Research Risks under 45 CFR 46.103.

A research entity eligible for a support grant from an NIH center.

A qualified nongovernmental research entity meeting NIH guidelines for center support grants.

Required for administration or provision of the item or service being evaluated, such as staffing and equipment needed to implant a device.

Required for clinically appropriate monitoring of the effects of the item or service.

Required for prevention, diagnosis, or treatment of complications from the item or service provided in the clinical trial.

The approving IRB must be AAHRPP-accredited.

Documentation Required

Trial Protocol and Qualified Facility

Maintain the written clinical trial protocol and documentation that the trial is conducted at a qualified facility where personnel have the training and expertise required to provide the type of care required by the study. The trial must be designed with therapeutic intent.

Keep the written protocol available for review.
Verify that the facility and personnel are qualified and appropriately trained for the study care.
Confirm that the clinical trial is designed to have a therapeutic intent.

Billing Rule

Clinical Trial Diagnosis Coding

Report ICD-10-CM code Z00.6 for all services provided as part of a qualified clinical trial or approved study, even when the service would otherwise be considered conventional care outside the trial.

Z00.6 identifies an encounter for examination of a participant in a clinical trial.
Use Z00.6 for all services furnished as part of the qualified clinical trial or approved study.

Denial Risk

Routine Care Must Meet Basic Coverage Requirements

Routine care costs are covered only when the same costs would typically be covered for a member who is not enrolled in the clinical trial, all items and services are medically necessary, and all items and services are covered benefits.

Routine care costs must relate to medically necessary care under the method being evaluated.
Coverage requires that the costs would typically be covered outside the trial.
Coverage requires that the items and services are covered benefits.

Denial Risk

Excluded Clinical Trial Costs

Do not bill CareSource for clinical-trial costs that are excluded from routine care coverage, including the evaluated item or service; services used only for data collection or analysis; items or services paid for or provided free by another source, including the sponsor; eligibility-testing services; toxicity- or disease-pathology-only trials; non-standard-of-care treatment supporting or administering the trial item or service; travel-related expenses; and experimental, investigational, or unproven care.

The item or service being evaluated is not a covered routine care cost.
Data collection and analysis services unrelated to direct clinical management are excluded.
Sponsor-paid or free items and services, and services used only to determine trial eligibility, are excluded.
Trials designed only to test toxicity or disease pathology are excluded.
Non-standard-of-care treatment used to support or administer the trial item or service is excluded.
Transportation, housing, food, and travel expenses for the member or companions are excluded.
Experimental, investigational, or unproven procedures, treatments, services, supplies, devices, and products are excluded.

Prior Authorization

Network and Utilization Management Limits

Routine care costs remain subject to all applicable plan limitations for out-of-network providers and all applicable utilization management requirements, including prior authorization.

Apply out-of-network coverage limitations when the provider is out of network.
Apply all utilization management guidelines to routine care furnished in the clinical trial.

DefinitionThe cost of medically necessary items and services related to the care method under evaluation in the clinical trial.

Medical necessityThe items and services must be medically necessary.

Relationship to trialThe items and services must relate to the care method being evaluated in the clinical trial.

Life-threatening disease or condition

Disease or conditionAny disease or condition from which death is probable.

Expected outcomeThe likelihood of death is probable unless the disease or condition is interrupted.

Interruption of courseThe condition is considered life-threatening when its course must be interrupted to prevent probable death.

Category A (Experimental) device

Risk statusA device for which the absolute risk of the device type has not been established.

Safety and effectivenessInitial questions of safety and effectiveness for the device type have not been resolved.

FDA positionThe FDA is unsure whether the device type can be safe and effective.

Category B (Non-experimental/investigational) device

Primary riskA device for which incremental risk is the primary risk in question.

Resolved device-type questionsInitial questions of safety and effectiveness for the device type have been resolved.

FDA approval or clearance exampleThe device type is known to be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type.

Experimental/investigational/unproven

Covered categoriesA procedure, treatment, service, supply, or product may be experimental, investigational, or unproven.

Institutional Review Board statusIt is subject to Institutional Review Board review or approval.

Evidence of effectivenessIts effectiveness on health outcomes is unproven based on clinical evidence in peer-reviewed medical literature.

Legal marketing statusIt cannot be legally marketed in the United States without final approval from the appropriate government regulatory or licensing body.

ICD-10-CM Code Z00.6

CodeICD-10-CM Z00.6.

Encounter descriptionA billable diagnosis code used to specify an encounter for examination for normal comparison and control in a clinical research program.

Participant examinationThe code reports that the service involved examination of a participant in a clinical trial.

Use in qualified studiesThe code must be used for all services provided as part of a qualified clinical trial or approved study, even if the service would otherwise be conventional care for the patient absent the trial.